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Asthma is a major public health problem. The main treatments against asthma are delivered to the lung through several dry-powder inhaler such as Turbuhaler ®, Diskus® and the new Ellipta® device. In real life, patient's ability to handle a device is not routinely assessed by their practitioner. We hypothesized that many asthmatics cannot properly prepare and prime their device, which may alter the positive effects observed in clinical trials.
The main objective of this study is to describe the handling of inhaler devices (Diskus®, Turbuhaler® and Ellipta®) in patients with asthma.
All participants will use each inhaler device (Diskus®, Turbuhaler® and Ellipta®) daily for one week:
For each inhaler device, 4 video recordings will be performed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® |
|
| Group 2 | Experimental | placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® |
|
| Group 3 | Experimental | placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo Diskus® | Device | device will be given daily for one week, two puffs per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Critical errors | Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist | Day 8 of each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Non device-dependent errors | Assessment of the presence of non device-dependent errors from standardized checklist with first device | Day 8 of each treatment |
| Time for drug administration | Measure of the necessary time for drug administration with each device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Olivier GIRODET, MD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Bordeaux | 33600 | France |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| placebo Ellipta® | Device | device will be given daily for one week, one puff per day |
|
| Pulmicort® Turbuhaler® | Device | device will be given daily for one week, two puffs per day |
|
| Day 8 of each treatment |
| Patient satisfaction questionnaire | Questionnaire of satisfaction about the use of each device | Day 8 of each treatment |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |